Kornimate/medical-research-clean huggingface dataset:
outcomes study to assess statin residual risk reduction with epanova in high cv risk patients with hypertriglyceridemia

Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)

Summary: the study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low hdl and high risk for cvd to be randomized 1:1 to either corn oil + statin or epanova + statin, once daily, for approximately 3-5 years as determined when the number of mace outcomes is reached.


Eligibility criteria:
inclusion criteria: 1. men or women, ≥18 years of age. 2. patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (visit 2) and meet the following criteria: 1. ldl-c \<100 mg/dl 2. tg level ≥180 and \<500 mg/dl and hdl-c \<42 mg/dl for men or hdl-c \<47 mg/dl for women 3. patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)\* is present via patient history, physical exam, or medical records at the time of screening: 1. any atherosclerotic cvd as defined in protocol. 2. history of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol. 3. male patients \>50 years of age or females \>60 years of age, with at least one of the risk factors defined in protocol. key exclusion criteria: 1. allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.use of fibrates, bile acid sequestrants, or niacin or its analogues (\>250 mg/day) within 4 weeks prior to visit 2. 3.statin naïve at visit 1.

Keywords: omega-3 carboxylic acid
demodex blepharitis treatment study

Conditions: Chronic Blepharitis

Summary: this is a randomized clinical trial to determine the safety and efficacy of terpinen-4-ol (t4o), the most active ingredient of tea tree oil (tto), in eradicating ocular demodicosis (reducing ocular demodex counts and achieving the clinical improvement with minimal or no irritation).

demodex blepharitis is one of the most common causes of chronic blepharitis. the investigators preliminary clinical study showed that lid scrub with tto was effective in resolving chronic blepharoconjunctivitis; however, it was not convenient for self-administration and caused irritation in some patients. preclinical safety studies have verified that t4o is less irritant. in this study, the investigators will determine the optimal regimen of t4o pads.

Eligibility criteria:
inclusion criteria: * patients with symptomatic demodex blepharitis for duration of at least 3 months. * age range: 15-80 years old. * both genders and all ethnic groups comparable with the local community. * able to understand and willing to sign a written informed consent * able and willing to cooperate with the investigational plan. * able and willing to complete all mandatory follow-up visits. exclusion criteria: * patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits. * children under 15. * pregnant women or expecting to be pregnant during the study. * systemic immune deficient conditions such as aids or under systemic immunosuppressant. * concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes). * concomitant use of systemic antibiotics or steroids. * contact lens wear (unless discontinued for ≥ 30 days before randomization) * active ocular infection or allergy * unable to close eyes or uncontrolled blinking * presence of aqueous tear deficient dry eye defined by the fluorescein clearance test as less than 3 mm wetting in 1-minute schirmer test with anesthesia. * previous allergic reaction to tto-containing products or cosmetic fragrance.

Keywords: blepharitis demodex mites tea tree oil terpinen
social capital and engagement in care among young black men who have sex with men living with hiv

Conditions: HIV Infections

Summary: the study is a randomized controlled trial to evaluate the social capital intervention versus a general health promotion intervention (health for life; h4l) among groups of young black men who have sex with men (ybmsm) and to measure the social capital and engagement in care with the hiv-positive ybmsm at 3 and 9 months.

young black men who have sex with men (ybmsm) have high rates of hiv infection, and are also at risk for falling out of clinical care. social capital, which refers to the resources in a person's social network, has been shown to be beneficial for people living with hiv in other places. the study wants to understand and build upon social capital in the ybmsm population in atlanta, with the goal of ultimately improving hiv-related outcomes for these youth. to achieve this study is conducted in 3 phases. in phase i, study will conduct interviews with ybmsm and community leaders to get advice about developing a social capital intervention that will improve social capital. phase ii is a randomized controlled trial of groups of ybmsm implementing the social capital intervention versus groups of ybmsm receiving a general health promotion intervention (health for life; h4l). this is followed by phase iii which is mainly to measure the social capital and engagement in care with the hiv-positive ybmsm at 3 and 9 month timepoints. the study plan to enroll 180 total participants (120 in the randomized controlled trial and 60 in preliminary interviews) over the four year study period.

Eligibility criteria:
inclusion criteria: * age \ = 18 years * self-identify as black/african-american (inclusive of multiracial identities) * male sex at birth * endorse history of sex with men ever (inclusive of gay and bisexual men) * hiv-positive (self-reported by participant and confirmed by medical record) * able and willing to provide written consent and participate in surveys, interviews, and/or group intervention exclusion criteria: * age \ = 30 years * unwilling or unable to provide written informed consent * enrollment in one phase of the study is an exclusion criteria for enrollment in other phases

Keywords: msm: men who have sex with men social capital
adjuvant chemotherapy trial of ts-1 for gastric cancer (acts-gc)

Conditions: Gastric Cancer

Summary: this controlled study is designed to evaluate the efficacy of ts-1 on survival compared with surgery alone. patients will be randomly assigned to receive either surgery alone or surgery followed by treatment with ts-1 within 45 days after curative resection (curability a or b). to assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. to evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.


Eligibility criteria:
inclusion criteria: * age 20 to 80 * hematopoietic wbc ≥ 4,000/mm\^3 platelet ≥ 100,000/mm\^3 * hepatic ast and alt ≤ 2.5 times upper limit of normal(uln) total bilirubin ≤ 1.5 mg/dl * renal creatinine ≤uln exclusion criteria: * prior anticancer treatment

Keywords: stomach cancer
an exploratory randomized controlled study of arthroscopic inlay bristow procedure for recurrent anterior shoulder dislocation

Conditions: Shoulder Dislocation

Summary: to evaluate the clinical and radiographic outcomes of arthroscopic inlay bristow procedure in treating recurrent anterior shoulder instability.

aim: to compare the clinical and radiographic outcomes following the arthroscopic chinese unique inlay bristow (cuistow) procedure and the arthroscopic bristow procedure. background: the cuistow procedure is a modified bristow surgery in which a mortise and tenon structure was added to the contact surface between the coracoid tip and the glenoid. in previous retrospective study, patients received cuistow procedure have satisfying clinical performance and excellent postoperative bone healing rate (96.1%). however, no prospective randomized controlled trial was performed. methods: 70 patients with recurrent anterior shoulder instability were included and randomized to either an arthroscopic cuistow procedure or arthroscopic bristow procedure. radiological evaluations with 3d ct scan were performed preoperatively, immediately after the operation, and postoperatively at three months and during the final follow-up (more than 2 years). clinical assessment for a minimum of 24 months including the 10-point visual analog scale for pain and subjective instability, university of california at los angeles scoring system (ucla score), american shoulder and elbow surgeons score (ases score), rowe score, subjective shoulder value (ssv) and active range of motion were completed by independent observers and analyzed.

Eligibility criteria:
inclusion criteria: * recurrent anterior shoulder instability based on medical history, physical examination, and radiological results. * a glenoid defect ≥10% but \<25% * participation in high-demand (collision and overhead) sports combined with the presence of a glenoid defect \<25% of the glenoid or without defect * failure after bankart repair exclusion criteria: * multi-directional shoulder instability * uncontrolled epilepsy * history of receiving bristow-latarjet procedure.

Keywords: bristow shoulder dislocation
digital nerve injury - a case control study

Conditions: Digital Nerve Injury

Summary: case control study, investigating what hand function and sensory function do patients perform 3-10 years following digital nerve injury and repair. the aim is to investigate if hand function is more limited following digital nerve injury in the thumb, index- and little finger, compared to less unburdened sensory surfaces in the fingers. secondary aim is to investigate the long term sensory function following digital nerve injury.

eligible patients are individuals treated at the department of hand surgery in stockholm, sweden during 2012-2018. inclusion criteria include diagnostic codes (icd-10) for a digital nerve injury in the thumb (s64.3) or finger (s64.4) in combination with the surgical code (kkå97) nomesco classification of surgical procedures for nerve repair (acb29). exclusion criteria are concomitant flexor tendon injury and/or skeletal injury, amputations, and severe soft tissue injuries. patients residing outside the stockholm region and children below 18 years of age are also excluded. initially a total number of 1330 patients have been identified. all medical records have been thoroughly scrutinized. after excluding concomitant tendon injury, a total of 606 patients remained with isolated digital nerve injury. a randomly selected sample of participants have been assigned to two groups: patients with an injury to the digital nerve of the thumb, digit ii radial side, digit v ulnar side were assigned to the "case" group and matched "controls" were randomly selected among patients with an injury to the digital nerves of either the ulnar side of digit ii, either nerve of digit iii and digit iv or the radial nerve of digit v. cases and controls have been matched according to sex, year of injury and patient age. for the purpose of this study, a clinical evaluation to investigate hand function, sensory function, strength, and ability to discriminate warm and cold and sharp and dull will be conducted. questionnaires are used for patient reported outcome measures (prom): disability of the arm shoulder, and hand (quickdash), patient questionnaire hq8 arm and hand (hq8), the hospital anxiety and depression scale (hads), saltin-grimby physical activity level scale (sgpals), and in addition douleur neuropathique en 4 questions (dn4) for assessment of neuropathic pain will be performed. all outcomes will be compared between groups defined as case (digital injury to the thumb, radial nerve of the index finger or ulnar nerve of the little finger) or control (all other digital nerve injuries).

Eligibility criteria:
inclusion criteria: * diagnostic codes (icd-10) for a digital nerve injury in the thumb (s64.3) or finger (s64.4) in combination with the surgical code (kkå97) nomesco classification of surgical procedures for nerve repair (acb29). * treatment completed in södersjukhuset hospital 2012 - 2018 exclusion criteria: * concomitant skeletal injury, * amputations * severe soft tissue injuries * microvascular reconstruction * residence outside the stockholm region * patient age below 18 years of age
vagal nerve stimulation as therapeutic approach on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: participants were randomly assigned to two groups prior to their second visit: the vagus nerve stimulation group (vns) and the circuit training program. the randomization processes were conducted in excel utilizing a random-number generator. prior to the second visit, each participants' target exercise heart rate ranges were determined. vagus nerve stimulation group(vns) patients rested on their sides in a sitting position. following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. the training regimen included ten different forms of resistance and aerobic exercises.

vagus nerve stimulation group group: 1. each participant signed a consent form after receiving a detailed explanation about the procedure. 2. patients rested on their sides in a sitting position. 3. disinfection of the stimulation locations. 4. ear clips were placed in the ear region (auricular concha) at the stimulation site. 5. emotional eating was assessed by emotional eating scale. 5. patient satisfaction was assessed by the short assessment of patient satisfaction (saps). 6. cortisol was assessed in lab. 7. after one month all the assessment procedure will be repeated again. circuit training group group: 1. each participant will signed a consent form after receiving a detailed explanation about the procedure. 2. the training regimen included ten different forms of resistance and aerobic exercises. 3. emotional eating was assessed by emotional eating scale. 4. patient satisfaction was assessed by the short assessment of patient satisfaction (saps). 5 cortisol was assessed in lab. 6. after one month all the assessment procedure will be repeated again.

Eligibility criteria:
inclusion criteria: having two or more than one of the following: * type 2 diabetes miletus * hypertensive. * abnormal cholesterol or triglyceride level. * bmi more than 30 kg/m * waist circumference more than 94 cm. exclusion criteria: * vagotomy. * diathermy. * wallowing difficulties. * dyspnea. * cardiac arrhythmia. * seizure. * previous brain injury or surgery. * dysautonomia.
sepsis post market observational study and potential reduction of time to antibiotics - baylor s&w

Conditions: Sepsis; Adult Disease; Emergency Department; Severe Sepsis

Summary: the purpose of this study is to demonstrate that addition of the monocyte width distribution (mdw) parameter to current standard of care improves a clinician's ability to recognize sepsis in the emergency department, resulting in earlier decision to administer antibiotics from time of ed presentation for sepsis patients (simulated primary endpoint), with concomitant reductions in length of stay and in-hospital mortality for those patients (secondary endpoints).

the objective of this study is to develop a method for identifying sepsis patients from electronic health records (ehr) based on sepsis-2 criteria. sepsis patients will be identified using a sepsis definition which includes meeting sirs score of ≥2 within 12 hours of ed presentation and any microbial testing ordered within 24 hours of ed presentation. the patient will be enrolled if it meets the sepsis definition and additional emr data elements will be extracted to complete case report form. furthermore, objectives include to confirm the clinical validity and performance of mdw in a control population of sepsis patients where mdw is measured but not reported to physicians. this study is an observational study which will simulate the decision impact of mdw on sepsis identification and patient management.

Eligibility criteria:
inclusion criteria: * adult (18 to 89 years) * all race and ethnicities * presenting to the emergency department with suspicion of infection * whose assessment includes a cbc with differential * meets emr sepsis definition exclusion criteria: * pregnancy * prisoners * transfers from other ed * previously enrolled
analgesic effects of cannabidiol for simple tooth extractions in dental patients

Conditions: Pain, Acute

Summary: the purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. participants will be randomized to one of four arms: treatment-as-usual (tau), cannabidiol 17mg/ml, cannabidiol 37mg/ml, or placebo.


Eligibility criteria:
inclusion criteria: * presenting for an operatory appointment at university of tennessee health science center college of dentistry oral and maxillofacial surgery department * operation must be a simple tooth extraction which does not result in an opioid prescription * 18 years of age or older * have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages exclusion criteria: * contraindication to ibuprofen * contraindication to acetaminophen * contraindication to cannabidiol or hemp oil * contraindication to peppermint oil * contraindication to almond or other tree nuts * currently taking a form of cannabidiol and unwilling to stop use for one week post surgery

Keywords: cannabidiol cbd acute pain alternative pain management simple extraction
randomized, prospective evaluation of the toad brace in plantar ulcer off-loading and healing

Conditions: Diabetic Foot; Pedal Ulcers

Summary: the toad medical corporation brace is a novel device that completely off-loads the foot and has been shown to heal ulcers at a rapid rate in preliminary experience in patients with plantar ulcers. this trial will attempt to show the efficacy of the toad brace and is based on the hypothesis that the toad brace completely offloads the foot and hastens healing rates of diabetic ulcers. the trial will randomize 74 patients with diabetic pedal ulcers to the toad brace or conventional therapy. . quantitative assessment of ulcer rate healing rates will be determined clinically and by blinded, computer-assisted planimetry of digital images over a 12 week period. the pressure on the plantar surface will be measured via a pressure sensor in a subset of patients. the trials will attempt to show markedly reduced pressure on the plantar surface and significantly higher ulcer healing rates with using the toad brace.


Eligibility criteria:
inclusion criteria: * men or women \>18 years old * one or more foot ulcers without clinical evidence of osteomyelitis * diagnosis of diabetes mellitus\* * university of texas grade 1a, 1c, 2a, or 2c ulcer15 * abi \>0.7 and toe pressure \>30mmhg exclusion criteria: * limited life-expectancy * wounds on calf or shin that would be in contact with the tag brace * gangrene, active infection * osteomyelitis of the foot with the ulcer * chronically bedridden/non ambulatory * unable to keep research appointments * wide spread malignancy or systemically immunocompromising disease * ipsilateral revascularization procedure within the last 30 days. * unreliable, unwilling or unable to comprehend informed consent
study of local anesthesia as a method to decrease iud insertion related pain

Conditions: IUD Insertion Complication; Pain Control

Summary: despite the high efficacy of intrauterine devices (iuds), some women choose not to receive iuds secondary to the pain associated with insertion. nulliparous women may be especially susceptible to procedure-related pain from iud insertion. this study will investigate the difference in perceived pain from iud insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. the investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with iud insertion will be significantly decreased after administration of local anesthesia.

the study will investigate the difference in perceived pain from iud insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and "functionally nulliparous" women. the investigators plan a double-masked, placebo controlled, randomized clinical trial. the investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with iud insertion will be significantly decreased after administration of a 15 ml 1% lidocaine paracervical block compared to patients who receive 15 ml of bacteriostatic saline (placebo).

Eligibility criteria:
inclusion criteria: * nulliparous and "functionally nulliparous" women receiving their first iud. "functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as \<4 cm dilation). * english speaking exclusion criteria: * presence of a centers for disease control medical eligibility criteria for contraceptive use category 3 or 4 precaution to a levonorgestrel iud * chronic narcotic use, current or past history of illegal drug use (excluding marijuana) * allergy to lidocaine

Keywords: intrauterine device paracervical block
multimodal assessment of liver volume and function

Conditions: Colorectal Cancer; Liver Metastases

Summary: in liver surgery peroperative assessment och the future liver remnant (flr) is pivotal in order to avoid posthepatectomy liver failure. to date this is mainly performed by measuring the volume of the flr. of course flr volume acts as a surrogate measure of flr function and the correlation between volume and function is not always accurate. several techniques to assess flr function has been proposed. hepatobiliary scintigraphy (hbs) and dynamic mri are the two such methods. in this study we compare hbs and mri, in addition to contrast-enhanced ct and icg, repeatedly performed before and after right hepatectomy in patients with colorectal liver metastases treated with neoadjuvant chemotherapy.


Eligibility criteria:
inclusion criteria: * crlm treated with neoadjuvant chemotherapy subjected to right hepatectomy exclusion criteria: -

Keywords: liver function future liver remnant chemotherapy